[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, self-crossover bioequivalence study of oral administration of idecalciferol soft capsules in Chinese healthy subjects on an empty stomach or after meals
主要目的:1.研究空腹状态下单次口服受试制剂艾地骨化醇软胶囊(规格:0.75μg,广州江正医药科技有限公司提供)与参比制剂艾地骨化醇软胶囊(Edirol;规格:0.75μg;持证商:中外製薬株式会社),通过比较受试制剂和参比制剂在空腹条件下健康受试者体内吸收代谢的药动学参数,评价两制剂的人体生物等效性。2.研究餐后状态下单次口服受试制剂艾地骨化醇软胶囊(规格:0.75μg,广州江正医药科技有限公司提供)与参比制剂艾地骨化醇软胶囊(Edirol?;规格:0.75μg;持证商:中外製薬株式会社),通过比较受试制剂和参比制剂在餐后条件下健康受试者体内吸收代谢的药动学参数,评价两制剂的人体生物等效性。
次要目的:评价中国健康受试者空腹和餐后状态下,单次口服受试制剂艾地骨化醇软胶囊和参比制剂艾地骨化醇软胶囊后的安全性。
[Translation] Main purpose: 1. To study the difference between the test preparation idecalcidol soft capsule (specification: 0.75 μg, provided by Guangzhou Jiangzheng Pharmaceutical Technology Co., Ltd.) and the reference preparation idecalcitol soft capsule (Edirol) in a single oral administration in the fasting state. ; Specification: 0.75μg; Licensee: Chugai Separation Co., Ltd.), by comparing the pharmacokinetic parameters of the test preparation and the reference preparation in vivo absorption and metabolism of healthy subjects under fasting conditions, the human biological properties of the two preparations are evaluated. effectiveness. 2. Study the single oral administration of the test preparation idecalcitol soft capsule (specification: 0.75 μg, provided by Guangzhou Jiangzheng Pharmaceutical Technology Co., Ltd.) and the reference preparation idecalcitol soft capsule (Edirol?) in the postprandial state; Specification: 0.75μg; Licensee: Chugai Seisakusho Co., Ltd.), by comparing the pharmacokinetic parameters of the test preparation and the reference preparation in vivo absorption and metabolism of healthy subjects under postprandial conditions, the human biological properties of the two preparations are evaluated. effectiveness.
Secondary purpose: To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation idecalcitol soft capsules and the reference preparation idecalcitol soft capsules in fasting and postprandial states.